The BARCODE 2 Study - The Use of Genetic Profiling to Guide Prostate Cancer Treatment
Status:
Recruiting
Trial end date:
2024-09-30
Target enrollment:
Participant gender:
Summary
Prostate cancer (PrCa) is one of the commonest cancer in men in the Western world, with over
40,000 new cases diagnosed each year in the United Kingdom (UK). Research studies have
identified several genetic changes that are thought to increase the risk of developing
prostate cancer. Some of these genetic changes occur in deoxyribonucleic acid (DNA) repair
genes. The BARCODE 2 trial is formed of two parts that aim to investigate how having genetic
changes in DNA repair genes can affect response to carboplatin treatment in patients with
metastatic castration resistant prostate cancer (mCRPC). In part 1 of the study, the
investigators will invite men with mCRPC who have not had genetic testing before to join the
study by initially undergoing genetic screening within the study. The DNA repair gene
mutation carrier status of enrolled patients will be assessed using a gene panel. If a
pathogenic mutation is confirmed in one of these genes, patients will be given the option to
proceed to part 2 of the study. In part 2 of the study, men with mCRPC who are known to be
carriers of a mutation in DNA repair gene(s) will be assessed for eligibility for treatment
on the study with carboplatin chemotherapy. The aim of the study will be to determine how
patients with mCRPC and a germline mutation in a DNA repair gene(s) respond to platinum
chemotherapy. This study will help researchers to investigate platinum sensitivity of
prostate tumours that have developed due to a germline mutation in a DNA repair gene. This
study will provide data to use in a larger clinical trial of platinum chemotherapy based on
patients' germline genetic signature and/or tumour genetic profile.
Phase:
Phase 2
Details
Lead Sponsor:
Institute of Cancer Research, United Kingdom
Collaborators:
Barts & The London NHS Trust Buckinghamshire Healthcare NHS Trust Chelsea and Westminster NHS Foundation Trust Colchester Hospital University NHS Foundation Trust Dartford and Gravesham NHS Foundation Trust East and North Hertfordshire NHS Trust European Research Council Frimley Park Hospital NHS Trust Great Ormond Street Hospital for Children NHS Foundation Trust Heatherwood and Wexham Park Hospitals NHS Foundation Trust Imperial College Healthcare NHS Trust Luton and Dunstable Hospital NHS Foundation Trust Maidstone & Tunbridge Wells NHS Trust Medway NHS Foundation Trust Mid and South Essex NHS Foundation Trust North Middlesex University Hospital NHS Trust Northampton General Hospital NHS Trust Nottingham University Hospitals NHS Trust Royal Devon and Exeter NHS Foundation Trust Royal Free Hampstead NHS Trust Royal Marsden NHS Foundation Trust Royal Surrey County Hospital NHS Foundation Trust Southend University Hospital Foundation NHS Trust The Whittington Hospital NHS Trust Whipps Cross University NHS Trust Yeovil District Hospital NHS Foundation Trust